Rethinking bioequivalence and equivalence requirements of orally inhaled drug products

Orally inhaled drug products (OIPs), such as corticosteroids and bronchodilators, are at the forefront of asthma and chronic obstructive pulmonary disease treatments, two diseases that afflict worldwide populations. Introducing generics of these products is essential, as the pricing of these medications remain a barrier to adequate patient care. Currently, there is no consensus between regulatory bodies as to the bioequivalence and equivalence requirements of OIPs that are intended for local action in the lungs. This manuscript critically reviews these requirements and presents future directions for clinicians, scientists, and regulators to consider to optimize the development and approval of OIPs.